Royal Oak Medical Devices
HELENA SYSTEM
SKU K110177UPC MAX
In Stock
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IIFDA 510(k) Cleared (K110177)
1
Free shipping on orders over $99 · 30-day returns
Royal Oak Medical Devices
Free shipping on orders over $99 · 30-day returns
HELENA SYSTEM is an FDA 510(k)-cleared medical device (K110177) manufactured by Royal Oak Medical Devices. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 20, 2011. Regulation: 8.
